Department of Mental Health and Addiction Services

Institutional Review Board - Office of the Commissioner

410 Capitol Avenue

PO Box 341431

Hartford, CT06134

INSTITUTIONAL REVIEW BOARD POLICY

TABLE OF CONTENTS

  1. Statement of Purpose …………………………………………………………...3
  2. Jurisdiction of DMHAS OOC IRB ………………………………………………3
  3. Applicability of Federalwide Assurance………………………………………..4
  4. Review of Research Where DMHAS is Not Engaged in the Research…….5
  5. Membership and Responsibilities ……………………………………………...5

A.Responsibilities of IRB Chair ……………………………………………... 6

B.Responsibilities of IRB Members ………………………………………... 6

  1. Conduct of Meetings ………………………………………………………….... 6
  2. IRB Records ……………………………………………………………………. 8

A.Research Files ……………………………………………………………...8

B.Minutes …………………………………………………………………….. ..8

C.IRB Membership ………………………………………………………….....9

  1. Types of IRB Review ……………………………………………………………9

A.Exempt from IRB Review …………………………………………………..9

B. Expedited Review …………………………………………………………10

C. Full Committee Review ………………………………………………….. 11

  1. Criteria for IRB Approval …………………………………………………….. 12

A.Basic Criteria ……………………………………………………………… 12

B.Requirements Related to Informed Consent …………………………...12

C.Requirements Related to the HIPAA Privacy Rule ……………………14

D.Additional Requirements Related to Specific Vulnerable

Populations……………………………………………………………….....14

E. Requirements Related to Confidentiality Certificates …………………..14

F. Requirements Related to Education of Key Research Personnel in

Protection of Human Subjects………………………………………….....15

  1. Authorization Agreements With Non-DMHAS Institutions………………….15
  2. Extending DMHAS’ Federalwide Assurance To Non-Assured

Institutions …… …………………………………………………………………16

  1. IRB Review Process ……………………………………………………………17

A.Initial Review ……………………………………………………………...... 17

B.Continuing Review ………………………………………………………….18

C.Review of Application for Approval of Revision ………………………… 20

  1. Notification of IRB Action ………………………………………………………21

A.Notification of Investigators ………………………………………………. 21

B.Notification of State-operated Facilities …………………………………..23

C.Notification of Institutions Engaged in an Authorization Agreement with DMHAS ……………………………………………………………………... 23

D.Notification of Institutional or Independent Investigators Covered by DMHAS’ Federalwide Assurance …………………………………………23

  1. Reporting of Unanticipated Problems ……………….………………………...24
  2. Reporting of Adverse Events …………………………………………………..24
  3. Reporting of Protocol Deviations ………………………………………………25
  4. Reporting of Study Related Complaints……………………………………….25
  5. Other Reportable Unanticipated Problems ……………………………..……26
  6. Reporting Unanticipated Problems Involving Risks to Study

Participants or Others, Serious or Continuing Non-compliance and

Suspension or Termination of IRB Approval to Institutional Officials

and Others ……………………………………………………………………….26

XX. Investigator Non-compliance …………………………………………………..26

XXI. Suspension or Termination of IRB Approval …………………………………27

  1. Final Report Upon Completion of Research ………………………………….28

Department of Mental Health and Addiction Services

Institutional Review Board - Office of the Commissioner

410 Capitol Avenue

PO Box 341431

Hartford, CT06134

INSTITUTIONAL REVIEW BOARD POLICY

I.STATEMENT OF PURPOSE

The purpose of this policy is to specify the manner in which research proposals will be reviewed, overseen and acted upon; in order to protect the rights and welfare of human research subjects participating in Department of Mental Health and Addiction Services (DMHAS) sponsored or approved research; and in order to comply with federal regulations regarding the protection of human subjects.

Compliance with Department of Health and Human Services (DHHS) regulations (Federal Policy for the Protection of Human Subjects, known as the Common Rule) is required wheneverDMHAS. becomes engaged in human subjects research conducted or supported by any federal department or agency that has adopted the Common Rule, unless the research is otherwise exempt from the requirements of the Common Rule or a department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance. Compliance with Food and Drug Administration (FDA) regulations is required when research involves products regulated by the FDA. .

DHHS regulations relating to the protection of human subjects are codified atTitle45 CFR Part 46 and are enforced by the Office of Human Research Protection (OHRP). The FDA regulations are codified at Title 21 CFR Part 5056 and are enforced by the FDA. In large part, the FDA regulations mirror 45 CFR 46 with some differences. Research conducted by or at DMHAS facilities most often falls under the jurisdiction of DHHS, but in the event of dual jurisdiction, both regulations apply.

II.JURISDICTION OF DMHAS OOC IRB

The Office of the Commissioner (OOC) Institutional Review Board (IRB) has jurisdiction over review and approval of activities categorized as research involving human subjects.

Research is defined by the regulations (45 CFR 46.102(d)) as a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

Human subjects are defined by the regulations (45 CFR 46.102(f) (1), (2)) as "living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information".

The OOC IRB will review, prospectively and on a continuing basis, research involving human subjects where the research is either sponsored or conducted by DMHAS or where the research is conducted by a non-DMHAS institution at a state operated facility. The OOC IRB is responsible and has authority to approve research, require modifications, disapprove research and suspend or terminate approval. (Because CMHC is jointly operated by both DMHAS and YaleUniversity, proposals for research to be conducted at CMHC are reviewed and approved by the Yale Human Investigations Committee unless the research will also be conducted at another DMHAS facility.)

When conducted by a non-DMHAS institution, not under contract by DMHAS, research must also be reviewed through a multi-stage process. This process is most usually initiated when the state-operated facility where the study recruitment or interventions will occur forwards a letter of endorsement to the DMHAS Research Director and theinvestigator forwards an IRB Application to the DMHAS IRB. Following receipt of both the letter of endorsement and the IRB Application, the DMHAS Research Director will initiate the Commissioner’s review, which involves review of scientific merit, review of administrative impact upon DMHAS and review of human subject protections by the IRB in accordance with federal regulations. Final approval by the Commissioner will be based upon IRB approval, a favorable assessment related to scientific merit and a favorable assessment related to administrative impact(see alsoReview of Research Where DMHAS is Not Engaged in the Research below)..

Research that has been reviewed and approved by the IRB may be subject to further review by the Commissioner ordesignee. However, another DMHAS body may not approve a research proposal that has been disapproved by the IRB.

III.APPLICABILITY OF FEDERALWIDE ASSURANCE

The terms of DMHAS’ Federalwide Assurance (FWA) apply whenever DMHAS becomes engaged in human subjects research conducted or supported by any federal department or agency that has adopted the Common Rule unless the research is otherwise exempt from the requirements of the Common Rule or a department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance. As such, DMHAS and the IRB designated under it’s assurance will comply with the Federal Policy for the Protection of Human Subjects (45 CFR 46 and subparts B,C, and D) when engaged in federally conducted or funded research.

The terms of DMHAS’ FWA have not been extended to non-federally conducted or supported research with humans; and DMHAS has not elected to assure application of 45 CFR 46 and subparts B,C and D to non-federally conducted or funded research with humans.

However when reviewing non-federally funded research the DMHAS IRB will generally apply the regulations and DMHAS IRB standards in the same manner as with federally funded research. But review and subsequent IRB actions in such cases is subject to flexibility as deemed appropriate by the IRB.

IV.REVIEW OF RESEARCH WHERE DMHAS IS NOT ENGAGED IN THE RESEARCH

Where an institution is not engaged in non-exempt human subject research, the regulations at 45 CFR 46 do not apply and IRB review is not required. However, there are circumstances where DMHAS is not engaged in research, but still elects to conduct prospective and ongoing IRB review of such research. This most generally occurs when a non-DMHAS institution or individual investigator requests permission to 1) conduct recruitment activities at a state-operated DMHAS facility; and/or 2) conduct research activities at a state-operated DMHAS facility.

When DMHAS reviews research as described above, the review and findings of the IRB are not subject to the regulations at 45 CFR 46. However in such cases the DMHAS IRB will generally apply the regulations and DMHAS IRB standards in the same manner as with all other research. But review and subsequent IRB actions in such cases is subject to flexibility as deemed appropriate by the IRB.

Please also see Expedited Review below for a detailed explanation of the criteria for expedited continuing review of research where DMHAS is not

engaged.

V.MEMBERSHIP AND RESPONSIBILITIES

The IRB will consist of at least five members. Members should be sufficiently diverse to enable adequate review of the range of research that is commonly reviewed by the Department. Membership will be constituted according to the following guidelines.

At least one member will fall into each of the following categories:

  • primary concern is in the scientific area
  • primary concern is in the non-scientific area
  • is not affiliated with DMHAS and is not part of the immediate family of a person who is affiliated with DMHAS.

When research under review is to include prisoner participants the convened IRB will include at least one member representing prisoner participants.

The individual designated as the Signatory Official for the DMHAS’ FWA will appoint the IRB chair and IRB members. Appointment will be for a two-year term. There is no limit on the number of terms the chair or a member may serve. New members may review and vote on IRB applications and other matters only after completion of new member orientation and education.

As deemed necessary, a specific individual may be designated as an alternate for a specific committee member. The alternate should, in general, have the same professional background, experience and expertise as the standing member. The Signatory Official also appoints alternate members and the alternate’s term is consistent with the standing member’s term. It is the standing members' responsibility to ensure that the alternate has adequate information and preparation related to specific issues and studies to enable the alternate to make an informed vote. Alternate members will receive all of the same IRB and study materials that standing members receive. Alternate members may attend any IRB meeting but may vote only in the absence of the standing member.

If any member anticipates an extended leave of absence (more than two meetings), due to unavoidable factors, the member may request to be categorized as “on temporary leave” from the committee. During the leave the member will not be considered when determining whether or not there is a quorum. Should the leave extend beyond six months the member will be withdrawn from the committee with the option of rejoining at a later date.

A.Responsibilities Of IRB Chair

The IRB Chair will either complete or ensure completion of the following tasks:

  • Compliance with regulations governing IRB activities
  • Scheduling of meetings
  • Preparation of agendas
  • Production of IRB minutes and distribution to IRB members
  • Maintenance of IRB records as outlined in this policy
  • Maintenance of a current list of all projects under the review of the IRB including actions taken and corresponding dates
  • Notification to investigators, and others as appropriate, of IRB action
  • Schedule timely continuation reviews
  • Conduct expedited reviews when applicable
  • Orientation of new members
  • Ongoing education
  • Represent the DMHAS IRB in communications with investigators, DMHAS staff, and others as required.

B.Responsibilities Of IRB Members

IRB members will be responsible for the following:

  • Regular attendance at IRB meetings
  • Review research proposals prior to the meetings in sufficient detail to enable informed voting
  • Vote on research proposals and other actions before the IRB committee.
  • Bring issues to the attention of the full committee as appropriate
  • Complete required educational activities

VI.CONDUCT OF MEETINGS

The IRB will meet monthly or at intervals sufficient to review new proposals, monitor ongoing studies and conduct the ongoing business of the committee.

Materials related to the studies scheduled for review will be distributed sufficiently in advance of the meeting to allow adequate time for review prior to the meeting.

Attendance sheets will be signed to document attendance.

Attendance of non-members at IRB meetings is by invitation only.

A quorum is achieved when a majority of members are in attendance. When the committee consists of an unequal number of members, the quorum is determined by dividing the number of members by 2 and rounding up by 1, e.g. if there are 5 members a quorum is reached with 3 members present. If the committee consists of an even number of members the quorum is determined by dividing the number of members by 2 and adding 1, e.g., if there are 6 members a quorum is reached with 4 members present. Once a quorum has been achieved issues can be decided based upon majority vote. Non-expedited research proposals may only be voted upon at a convened meeting where there is a quorum and where attendance includes one member whose primary interest is in non-scientific areas. If a quorum is lost during the meeting no further action (voting) may be taken in relation to the studies under review. Minutes of the meeting should reflect loss of the quorum and the reason for the loss, e.g. early departure, etc.

As necessary, members who have received and have access to materials related to the study(ies) under review may participate in deliberations and may vote via teleconference. Members participating via teleconference are included as part of the quorum. Minutes of the meeting should reflect participation via teleconference.

Members who will be absent from a meeting may submit their comments related to studies under review. These comments will be shared with the full committee; however the absent member may not vote.

When deemed necessary, the IRB may invite individuals with expertise and knowledge in specialized areas for the purpose of providing consultation and opinion regarding a proposal. However, these individuals may not vote.

The principal investigator or their designee will be invited to attend the IRB review, in person or via teleconference, in order to respond to questions raised by IRB members. The principal investigator or their designee cannot be present during the IRB’s final discussion and vote.

Members who are not directly involved in a research project may still experience a conflict of interest regarding their IRB role based upon a variety of factors, e.g. past or present work or personal relationship with PI or member of the research team.Members will attest to a lack of conflict of interest for each proposal that they review and vote on by signing a Conflict of Interest Declaration. An IRB member who has a conflict of interest related to a study under review may not participate in the review other than to provide information about the proposal. A member with a conflict of interest is not required to absent the room during final discussion and vote; but may absent the room depending on the degree of conflict as reported by the member with the conflict, the comfort of the IRB member with the conflict and the opinion of the IRB committee. Members with a conflict of interest will recuse themselves from the vote.

VII.IRB RECORDS

The IRB Chair will ensure that records are maintained in a manner sufficient to adequately document IRB activities. IRB records, including specific study files, will be maintained at the Office of the Commissioner

Documentation will be maintained as outlined below.

A.Research Files

Research files will contain the following:

  • IRB Application/proposal
  • Grant proposal, if applicable
  • Conflict of Interest Declaration
  • Approved protocol, consent form and other material related to approved study with approval and approval expiration dates affixed by the IRB Chair
  • Application for continued approval
  • Notification of IRB action(s)
  • Correspondence related to study
  • Statements of significant new findings provided to subjects
  • Reports of adverse events
  • Minutes of meetings where the study was discussed
  • Other documents as deemed relevant

B.Minutes

Minutes will be maintained for all IRB meetings and will reflect the following information:

  • Meeting date and location
  • Attendance and whether a quorum was achieved; loss of quorum
  • Research proposals reviewed
  • Type of review
  • Summary of discussions of controverted issues and their resolution
  • Where HHS regulations require specific findings on the part of the IRB, documentation of the findings and, where necessary, protocol-specific information related to each finding.
  • IRB action including total number in attendance and members voting for, against and abstaining.
  • Time frame for approval, i.e., one year, 6 months, etc
  • Basis for requiring changes and for disapproval.
  • Other activity of the committee.

Minutes may be forwarded to members prior to regularly scheduled meetings in order to enable review and feedback by all members. Minutes will be formally approved at convened meetings. Minutes are confidential and are available only to IRB members, the signatory official related to the DMHAS Federalwide Assurance, and the person to whom the IRB Chair directly reports, unless the latter two are involved in the research under question, in which case minutes would not be available to these parties.

C.Report of IRB Activity during a Month when a Convened Meeting is Not Held

There are months when an IRB meeting is not held. This occurs primarily when there are no studies scheduled for review, or when the studies that are scheduled are reviewed by an expedited process. When the monthly meeting is not held, the chair will provide a report of the reviews conducted and any other activity that would routinely be contained within the Agenda and/or IRB Minutes. There is no specified time frame for completing this report, but it will generally be forwarded to committee members sometime after the date of the missed meeting and before the next regularly scheduled meeting. Reports of IRB Activity are not approved by the committee, but committee members are free to pose questions, make comments and/or raise issues about topics covered in the report.

D. IRB Membership

A list of IRB members will be maintained containing the following information:

  • Name
  • Earned degree
  • Representative capacity
  • Indication of experience sufficient to describe chief anticipated contribution
  • Employment status with or relationship to DMHAS.

Records related to the conduct and documentation of IRB activities will be maintained for three years. Specific research files will be maintained for at least three years after completion of the research.